Top Shelf Orthopedics 508210

GUDID 00850016589460

Circulating-fluid localized thermal therapy system pack, single-use

Primary Device ID	00850016589460
NIH Device Record Key	a2bb05fb-7877-4b04-8abd-63c165992947
Commercial Distribution Status	In Commercial Distribution
Brand Name	Top Shelf Orthopedics
Version Model Number	508210
Catalog Number	508210
Company DUNS	114134625
Company Name	Top Shelf Manufacturing, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00850016589460 [Primary]

ILO	Pack, Hot Or Cold, Water Circulating

Steralize Prior To Use	false
Device Is Sterile	false

10850016589047	530016
10850016589030	530015
10850016589023	530003
10850016589016	530002
10850016589009	Shoulder Holder
00850016589224	TLSO Brace
00850016589217	TLSO Brace
00850016589200	TLSO Brace
00850016589194	TLSO Brace
00850016589187	TLSO Brace
00850016589484	Knee Pad, Sierra Cold Therapy System
00850016589477	Multiuse Pad, Sierra Cold Therapy System
00850016589460	Shoulder Pad, Sierra Cold Therapy System
00850016589422	Sierra Cold Therapy System with Shoulder Pad
00850016589415	Sierra Cold Therapy System with Multiuse Pad
00850016589408	Sierra Cold Therapy System

Mark Image Registration \| Serial	Company Trademark Application Date
TOP SHELF ORTHOPEDICS 77506306 3661847 Live/Registered	TOP SHELF MANUFACTURING, LLC 2008-06-24